CN117257909A - Traditional Chinese medicine composition for treating breast nodules and preparation method of solubilizing preparation of traditional Chinese medicine composition - Google Patents

Traditional Chinese medicine composition for treating breast nodules and preparation method of solubilizing preparation of traditional Chinese medicine composition Download PDF

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CN117257909A
CN117257909A CN202311457845.9A CN202311457845A CN117257909A CN 117257909 A CN117257909 A CN 117257909A CN 202311457845 A CN202311457845 A CN 202311457845A CN 117257909 A CN117257909 A CN 117257909A
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chinese medicine
traditional chinese
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medicine composition
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施秦
王亚男
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Jiangsu Vocational College of Medicine
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Abstract

The invention provides a traditional Chinese medicine composition which comprises selfheal, pinellia ternate, frankincense, fingered citron, nutgrass galingale rhizome, weeping forsythiae capsule, ginger, liquorice, dried rehmannia root and Chinese angelica. The traditional Chinese medicine composition has the effects of regulating qi and blood, both principal and secondary aspects of disease, dispersing stagnated liver qi, promoting blood circulation, resolving phlegm, softening and resolving hard mass, nourishing blood, tranquillizing, and has the advantages of eliminating pathogenic factors without damaging the vital energy, and solves the problem that breast nodules cannot be thoroughly cured. After the Chinese medicine solubilization preparation provided by the invention is contacted with water, the medicine can be dispersed, the solubility of the medicine is increased, the medicine release is promoted, and the medicine effect is enhanced.

Description

Traditional Chinese medicine composition for treating breast nodules and preparation method of solubilizing preparation of traditional Chinese medicine composition
Technical Field
The invention relates to the technical field of traditional Chinese medicine pharmacy, in particular to a traditional Chinese medicine composition and a preparation method of a solubilizing preparation thereof.
Background
Breast nodules are structural degenerative changes and progressive connective tissue growth of the breast tissue ducts and lobules, common to hyperplasia of the breast (which can form breast cysts) and neoplastic diseases of the breast, including benign tumors of the breast (e.g., fibroadenoma, lobular tumors, etc.) and malignant tumors of the breast (breast cancers). The traditional Chinese medicine holds that: the patients with unsmooth feeling, abnormal liver qi, stagnation of qi and blood, and disharmony of thoroughfare and conception vessels often have menstrual disorder and facial spots. Modern medicine holds that: the external environment and genetic factors of wedding, diet, human survival are the main causes of breast morbidity. Modern western medicine considers that: the external environment and genetic factors of wedding, diet, human survival are the main causes of breast morbidity. Because patients lack correct knowledge of the disease, bad psychological factors, excessive tension, sadness and the like cause neurasthenia, greatly aggravate endocrine dyscrasia and promote aggravation of diseases. At present, the breast nodules are mostly treated by adopting an operation method, and the existing traditional Chinese medicine preparation has a common treatment effect on the formed nodules, can only inhibit the growth expansion of the nodules, and cannot eliminate the nodules.
In addition, the traditional Chinese medicine preparation prepared by taking traditional Chinese medicine powder as raw materials in the traditional Chinese medicine production process has the defect of low solubility.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating breast nodules and a preparation method of a solubilizing preparation thereof.
In order to achieve the above object, the present invention provides the following technical solutions:
the invention provides a traditional Chinese medicine composition, which comprises the following traditional Chinese medicine raw materials in parts by weight: 15-30 parts of selfheal, 5-10 parts of pinellia tuber, 12-18 parts of frankincense, 8-13 parts of fingered citron, 5-10 parts of nutgrass galingale rhizome, 3-8 parts of weeping forsythiae capsule, 6-9 parts of ginger, 3-6 parts of liquorice, 6-12 parts of dried rehmannia root and 7-15 parts of Chinese angelica.
Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 18-25 parts of selfheal, 6-8 parts of pinellia tuber, 15-17 parts of frankincense, 9-11 parts of fingered citron, 7-9 parts of nutgrass galingale rhizome, 5-7 parts of weeping forsythiae capsule, 7-8 parts of ginger, 4-5 parts of liquorice, 8-10 parts of dried rehmannia root and 9-13 parts of Chinese angelica.
The invention also provides a solubilization preparation of the traditional Chinese medicine composition, which comprises the traditional Chinese medicine extract dry powder and medicinal auxiliary materials, wherein the medicinal auxiliary materials comprise a nonionic surfactant, a glidant, a lubricant and an adhesive; the weight ratio of the dry powder of the traditional Chinese medicine extract to the auxiliary materials of the medicine is 78-90:10-22.
Preferably, the nonionic surfactant is a nonionic surfactant having polyethylene glycol as a hydrophilic group.
Preferably, the nonionic surfactant is selected from tween, polyoxyethylated castor oil, polyoxyethylated hydrogenated castor oil or vitamin E polyethylene glycol succinic acid.
Preferably, the weight ratio of the nonionic surfactant, the glidant, the lubricant and the binder is as follows: 10-20:0.4-0.8:0.5-1.2:0.03-0.06.
The invention also provides a preparation method of the solubilization preparation of the traditional Chinese medicine composition, which comprises the following steps:
s1, putting the traditional Chinese medicine raw material sections into liquid nitrogen, and freezing for 15-25 min;
s2, grinding the traditional Chinese medicine raw material segments frozen by liquid nitrogen, adding liquid nitrogen again every 4-7 min, grinding to 80-100 meshes, drying, decocting, concentrating and spray-drying the traditional Chinese medicine powder to obtain extract dry powder;
s3, mixing the extract dry powder with a nonionic surfactant, a glidant and an adhesive to obtain a mixture 1;
s4, mixing the mixture 1 with a lubricant, and tabletting to prepare the traditional Chinese medicine composition solubilization preparation.
Preferably, the length of the traditional Chinese medicine section is 0.3-0.5 cm.
Preferably, the grinding time in the step S2 is 50-55 min; the temperature of the drying is 40-50 ℃.
Preferably, the volume ratio of the traditional Chinese medicine section to the liquid nitrogen in the S1 is as follows: 1-2:10.
By adopting the technical scheme, the invention has the following beneficial effects: the traditional Chinese medicine for treating breast nodules has reasonable compatibility and elegant formula. Wherein, the selfheal can dissipate stagnation and reduce swelling as a monarch drug; rhizoma cyperi has the effects of soothing liver-qi stagnation, regulating qi, relieving middle-jiao, regulating menstruation, relieving pain, eliminating dampness and phlegm, relieving stuffiness and eliminating stagnation, activating blood circulation, promoting qi circulation, relieving pain, activating collaterals, regulating qi-flowing for reducing phlegm, soothing liver-qi stagnation, clearing heat, detoxicating, resolving stagnation and relieving swelling, and is taken as a ministerial drug; the radix rehmanniae has the effects of nourishing yin and blood, nourishing yin and promoting the production of body fluid, enriching blood and moistening dryness of Chinese angelica, assisting the radix rehmanniae to nourish yin and blood, nourishing heart and tranquillizing, and the ginger not only assists the pinellia ternate and the dried orange peel to reduce phlegm and harmonize the middle-jiao, but also can restrict the toxicity of the pinellia ternate, and is used as an adjuvant drug; licorice root, radix Glycyrrhizae Praeparata has the effects of replenishing qi, strengthening the spleen and regulating the middle warmer, and harmonizing the drugs, and is used as a guiding drug. The traditional Chinese medicine composition has the effects of regulating qi and blood, both principal and secondary aspects of disease, dispersing stagnated liver qi, promoting blood circulation, resolving phlegm, softening and resolving hard mass, nourishing blood, and tranquillizing, and has the advantages of eliminating pathogenic factors without damaging the body resistance.
The Chinese medicine solubilisation preparation of the invention has better compatibility with auxiliary materials and extract dry powder, and is uniformly dispersed to form a dissolving tablet with the characteristic of solid dispersion. The invention utilizes the characteristic of quick dissolution of nonionic surfactant, and the tablet can disperse the medicine after meeting water, increase the solubility of the medicine, promote the release of the medicine and enhance the medicine effect.
Detailed Description
The invention provides a traditional Chinese medicine composition, which comprises the following traditional Chinese medicine raw materials in parts by weight: 15-30 parts of selfheal, 5-10 parts of pinellia tuber, 12-18 parts of frankincense, 8-13 parts of fingered citron, 5-10 parts of nutgrass galingale rhizome, 3-8 parts of weeping forsythiae capsule, 6-9 parts of ginger, 3-6 parts of liquorice, 6-12 parts of dried rehmannia root and 7-15 parts of Chinese angelica.
In the present invention, the weight part of the selfheal is preferably 15 to 30 parts, more preferably 18 to 25 parts, and even more preferably 22 parts.
In the present invention, the weight part of pinellia ternate is preferably 5 to 10 parts, more preferably 6 to 8 parts, and even more preferably 7 parts.
In the present invention, the weight part of the olibanum is preferably 12 to 18 parts, more preferably 15 to 17 parts, and even more preferably 16 parts.
In the present invention, the weight part of fingered citron is preferably 8 to 13 parts, more preferably 9 to 11 parts, and even more preferably 10 parts.
In the present invention, the weight part of nutgrass galingale rhizome is preferably 5 to 10 parts, more preferably 7 to 9 parts, and still more preferably 8 parts.
In the present invention, the weight part of fructus forsythiae is preferably 3 to 8 parts, more preferably 5 to 7 parts, and still more preferably 6 parts.
In the present invention, the weight part of ginger is preferably 6 to 9 parts, more preferably 7 to 8 parts.
In the present invention, the weight part of licorice is preferably 3 to 6 parts, more preferably 4 to 5 parts.
In the present invention, the weight part of the dried rehmannia root is preferably 6 to 12 parts, more preferably 8 to 10 parts, and even more preferably 9 parts.
In the present invention, the weight part of angelica is preferably 7 to 15 parts, more preferably 9 to 13 parts, and still more preferably 11 parts.
The invention also provides a solubilization preparation of the traditional Chinese medicine composition, which comprises the traditional Chinese medicine extract dry powder and medicinal auxiliary materials, wherein the medicinal auxiliary materials comprise nonionic surfactant, glidant, lubricant or adhesive; the weight ratio of the dry powder of the traditional Chinese medicine extract to the auxiliary materials of the medicine is 78-90:10-22.
In the invention, the nonionic surfactant is a nonionic surfactant taking polyethylene glycol as a hydrophilic group.
In the present invention, the nonionic surfactant is selected from tween, polyoxyethylene castor oil, polyoxyethylene hydrogenated castor oil or vitamin E polyethylene glycol succinic acid.
In the present invention, the glidant is preferably talc or silica gel micropowder.
In the present invention, the lubricant is preferably stearate, hydrogenated vegetable oil, more preferably calcium stearate or magnesium stearate.
In the present invention, the binder is preferably starch, methylcellulose, sodium carboxymethylcellulose.
In the invention, the weight ratio of the nonionic surfactant, the glidant, the lubricant and the adhesive is preferably as follows: 10-20:0.4-0.8:0.5-1.2:0.03-0.06; further preferably 13 to 18:0.5 to 0.7:0.8 to 1.0:0.04 to 0.05, more preferably 15:0.6:0.9:0.05.
The invention also provides a preparation method of the solubilization preparation of the traditional Chinese medicine composition, which comprises the following steps:
s1, putting the traditional Chinese medicine raw material sections into liquid nitrogen, and freezing for 15-25 min;
s2, grinding the traditional Chinese medicine raw material segments frozen by liquid nitrogen, adding liquid nitrogen again every 4-7 min, grinding to 80-100 meshes, drying, decocting, concentrating and spray drying the traditional Chinese medicine powder to obtain extract dry powder;
s3, mixing the extract dry powder with a nonionic surfactant, a glidant and an adhesive to obtain a mixture 1;
s4, mixing the mixture 1 with a lubricant, and tabletting to prepare the traditional Chinese medicine composition solubilization preparation.
In the invention, the impurities and mildewed products in the traditional Chinese medicine raw materials are preferably removed, and the traditional Chinese medicine raw materials are cleaned by clean water and dried. The invention cleans and dries the traditional Chinese medicine raw materials, and cuts the traditional Chinese medicine raw materials into sections, wherein the cutting length is preferably 0.3-0.5 cm.
The invention preferably comprises the steps of putting the cut traditional Chinese medicine into liquid nitrogen for freezing and grinding; the time for the freezing is preferably 15 to 25 minutes, more preferably 17 to 22 minutes, and still more preferably 20 minutes; liquid nitrogen is preferably added again every 4-7 min in the grinding process, so as to avoid the high temperature generated by grinding to destroy the drug effect or avoid the traditional Chinese medicine raw materials from being sticky and soft when being heated, thus causing insufficient grinding fineness; the fineness of the grinding is preferably 80 to 100 mesh, and the grinding is preferably performed in a fully automatic freeze mill.
After the traditional Chinese medicine fine powder is obtained, the traditional Chinese medicine fine powder is decocted, concentrated and spray-dried to obtain extract dry powder; the times of the decoction are preferably 2 times, and the time of each decoction is preferably 50-60 min, and more preferably 55min; the concentration is preferably rotary evaporation concentration, the rotating speed of the rotary evaporation concentration is preferably 150-180 rpm, more preferably 160rpm, and the temperature of the rotary evaporation concentration is 80-95 ℃, more preferably 85 ℃; the spray drying temperature is preferably 100 to 120 ℃, preferably 110 ℃.
Mixing the extract dry powder with nonionic surfactant, glidant and binder to obtain a mixture 1; mixing the mixture 1 with a lubricant, and tabletting to obtain the Chinese medicinal composition solubilization preparation.
The technical solutions provided by the present invention are described in detail below with reference to examples, but they should not be construed as limiting the scope of the present invention.
Example 1
15kg of common selfheal fruit-spike, 5kg of pinellia tuber, 12kg of frankincense, 8kg of fingered citron, 5kg of nutgrass galingale rhizome, 3kg of weeping forsythiae capsule, 6kg of ginger, 3kg of liquorice, 6kg of dried rehmannia root and 7kg of Chinese angelica are taken, cleaned by clean water after impurity removal, dried and cut into small sections of 0.3-0.5 cm, the small sections are frozen by liquid nitrogen for 15min for grinding, the liquid nitrogen is added again every 4min in the grinding process, the high temperature generated by grinding is avoided, and the small sections are ground to 80 meshes of Chinese medicinal powder. Liquid nitrogen milling was performed in a fully automated liquid nitrogen cryomill JXFSTPRP-II-01 (tuohz electro mechanical technology Shanghai limited). 2 times of decoction are carried out on the traditional Chinese medicine powder, and each time of decoction is carried out for 50min; concentrating the decoction by rotary evaporation at 150rpm, and spray drying at 100deg.C to obtain dry extract powder. Mixing 78g of extract dry powder with 10g of Tween 80, 0.4g of talcum powder and 0.03g of starch, adding 0.5g of magnesium stearate, mixing, tabletting and 0.5g of each tablet to prepare the traditional Chinese medicine composition solubilization preparation.
Example 2
30kg of common selfheal fruit-spike, 10kg of pinellia tuber, 18kg of frankincense, 8kg of fingered citron, 10kg of nutgrass galingale rhizome, 8kg of weeping forsythia, 9kg of ginger, 6kg of liquorice, 12kg of dried rehmannia root and 15kg of Chinese angelica are taken, cleaned by clean water after impurity removal, dried and cut into small sections of 0.3-0.5 cm, the small sections are frozen by liquid nitrogen for 25min for grinding, the liquid nitrogen is added again every 7min in the grinding process, the high temperature generated by grinding is avoided, and the traditional Chinese medicine powder is obtained after grinding to 100 meshes. Liquid nitrogen milling was performed in a fully automated liquid nitrogen cryomill JXFSTPRP-II-01 (tuohz electro mechanical technology Shanghai limited). Decocting the Chinese medicinal powder for 2 times, each time for 60min, rotary evaporating and concentrating the decoction at 180rpm, and spray drying at 120deg.C to obtain dry extract powder. Mixing 90g of extract dry powder with 20g of polyoxyethylene castor oil, 0.8g of micro silica gel and 0.06g of methyl cellulose, adding 1.2g of calcium stearate, mixing, tabletting and 0.5g of each tablet to prepare the traditional Chinese medicine composition solubilization preparation.
Example 3
20kg of common selfheal fruit-spike, 7kg of pinellia tuber, 15kg of frankincense, 10kg of fingered citron, 8kg of nutgrass galingale rhizome, 5kg of weeping forsythiae capsule, 6kg of ginger, 5kg of liquorice, 9kg of dried rehmannia root and 11kg of Chinese angelica are taken, cleaned by clean water after impurity removal, dried and cut into small sections of 0.3-0.5 cm, the small sections are frozen by liquid nitrogen for 20min for grinding, the liquid nitrogen is added again every 5min in the grinding process, the high temperature generated by grinding is avoided, and the traditional Chinese medicine powder is obtained after grinding to 100 meshes. Liquid nitrogen milling was performed in a fully automated liquid nitrogen cryomill JXFSTPRP-II-01 (tuohz electro mechanical technology Shanghai limited). Decocting the Chinese medicinal powder for 2 times, each time for 55min, rotary evaporating and concentrating the decoction at 160rpm, and spray drying at 110deg.C to obtain dry extract powder. Mixing 85g of extract dry powder with 15g of vitamin E polyethylene glycol succinic acid, 0.6g of talcum powder and 0.04g of sodium carboxymethyl cellulose, adding 0.9g of hydrogenated vegetable oil after uniformly mixing, and tabletting, wherein each tablet is 0.5g, so as to prepare the traditional Chinese medicine composition solubilization preparation.
Comparative example 1
Comparative example 1 compared with example 1, no mastic was added, and the remaining components and preparation method were the same as in example 1.
Comparative example 2
Comparative example 2 was compared with example 1, no fingered citron was added, and the remaining components and preparation method were the same as example 1.
Comparative example 3
Comparative example 3 compared with example 1, no nutgrass galingale rhizome was added, and the other components and preparation method were the same as in example 1.
Comparative example 4
Comparative example 4 in comparison with example 1, no fructus forsythiae was added, and the remaining components and preparation method were the same as in example 1.
Comparative example 5
Comparative example 5 in comparison with example 1, ginger was not added, and the remaining components and preparation method were the same as in example 1.
Comparative example 6
Comparative example 6 in comparison with example 1, no licorice was added, and the remaining components and preparation method were the same as in example 1.
Comparative example 7
Comparative example 7 compared with example 1, no radix rehmanniae was added, and the remaining components and preparation methods were the same as example 1.
Comparative example 8
Comparative example 8 compared with example 1, no angelica was added, and the remaining components and preparation method were the same as example 1.
Comparative example 9
Comparative example 9 compared with example 1, no tween 80 was added, and the remaining components and preparation method were the same as in example 1.
Experimental example 1 treatment effect experiment
(1) Basic data: applied to 270 cases of female clinical observation, the ages of 20-65 years, the cases are divided into 9 groups based on the treatment mode difference of patients, and 30 patients in each group.
(2) Inclusion criteria: breast distending pain at ordinary times or before menstrual period, breast ultrasound suggests nodules or masses.
(3) The usage amount is as follows: the first to ninth groups each orally received the medicaments prepared in example 1 and comparative examples 1 to 9, 3 to 5 tablets each time, twice daily, for 3 months.
(4) Standard of efficacy:
and (3) curing: the symptoms of breast nodules, lump swelling pain and discomfort completely disappear, and color Doppler ultrasound detection prompts the complete disappearance of the breast nodules or lump;
the effect is shown: the symptoms of breast nodules and lump distending pain and discomfort are obviously relieved, and color Doppler ultrasound detection prompts the disappearance or shrinkage of the breast nodules or lump part;
the method is effective: partial relief of symptoms of breast nodules, lump distending pain and discomfort, and color Doppler ultrasound detection prompts shrinkage of the breast nodules or lump;
invalidation: the symptoms of breast nodules, lump distending pain and discomfort are not relieved, and color Doppler ultrasound detection indicates that the breast nodules or lump are not changed or enlarged.
(5) The treatment effect is as follows: the treatment was carried out for 3 months by taking the solubilised formulations of the Chinese medicinal compositions of example 1 and comparative examples 1 to 8, and the specific therapeutic effects of each group are shown in Table 1:
table 1 therapeutic Effect of solubilised formulations of Chinese medicinal compositions
Clinical example 1
Women, 30 years old, have breast nodules for two years, and patients complain about dry mouth, bitter taste, vexation, irritability, insomnia, dreaminess, repeated swelling pain or stinging of the breast and aggravated menstrual period. Ultrasound is represented by: the acoustic structure of the fascia layers of the double breast skin is not abnormal. The right gland tissue has a circular slightly hypoechoic, approximately 1.0x1.2cm in size and smooth edges in the outer lower quadrant. The left breast had a capsule hyperechoic, another see a hypoechoic of about 0.3x0.2 CM in size. Boundary cleaning, CDFI: the above-mentioned circle shows a blood flow signal in a slightly lower echo.
Western diagnosis: bilateral nodule of mammary gland
Diagnosis of traditional Chinese medicine: nodules of breast, qi stagnation and blood stasis, phlegm stagnation and accumulation
The treatment method comprises the following steps: liver soothing, blood circulation activating, dampness eliminating, phlegm resolving, mass resolving and swelling eliminating effects
The Chinese medicinal composition solubilizing preparation is taken twice a day, 3-5 tablets each time, and 3 months continuously.
Curative effect: after 1 month, the patient is re-diagnosed, and the symptoms of dry mouth, bitter taste, vexation, irritability, insomnia and dreaminess are obviously improved. After taking the medicine for 2 months, the symptoms of mammary gland distending pain and stabbing pain are obviously reduced, the color Doppler ultrasound prompts that the lower quadrant of the right gland tissue has a circular shape with slightly lower echo, the size is about 0.5 multiplied by 0.4CM, and the left mammary gland is not abnormal; after 3 months of administration, symptoms of breast distending pain and stinging pain disappear, and color ultrasonic re-examination shows that: no abnormalities were seen in the bilateral mammary glands.
Experimental example 2 solubility experiment of Chinese medicinal composition solubilizing preparation
1.0g of the samples of example 1 and comparative example 9 were weighed into 100ml volumetric flasks and dissolved in a constant volume with a shaking of Shui Zhen. Taking a glass sand core funnel, drying in a 105 ℃ oven for 30min, then placing in a dryer to room temperature, taking out, weighing together with filter paper, marking as W1, filtering the solution by using the weighed sand core funnel, placing the filtered sintered funnel together with the filter paper in the oven, drying at 105 ℃ for 30min, taking out, placing in the dryer to room temperature, taking out, weighing, and marking as W2.
The solubility of the solubilizers of the Chinese medicinal compositions of example 1 and comparative example 9 are shown in Table 2:
table 2 solubility of solubilizing agent for the Chinese medicinal compositions of example 1 and comparative example 9
W1(g) W2(g) Dissolution Rate (%)
Example 1 61.112 61.175 93.7%
Comparative example 9 61.118 61.264 85.4%
As can be seen from table 2, the solubility of the solubilizing agent of the traditional Chinese medicine composition in the present application was enhanced.
The foregoing is merely a preferred embodiment of the present invention and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the present invention, which are intended to be comprehended within the scope of the present invention.

Claims (10)

1. The traditional Chinese medicine composition is characterized by comprising the following traditional Chinese medicine raw materials in parts by weight: 15-30 parts of selfheal, 5-10 parts of pinellia tuber, 12-18 parts of frankincense, 8-13 parts of fingered citron, 5-10 parts of nutgrass galingale rhizome, 3-8 parts of weeping forsythiae capsule, 6-9 parts of ginger, 3-6 parts of liquorice, 6-12 parts of dried rehmannia root and 7-15 parts of Chinese angelica.
2. The traditional Chinese medicine composition according to claim 1, which is characterized by comprising the following components in parts by weight: 18-25 parts of selfheal, 6-8 parts of pinellia tuber, 15-17 parts of frankincense, 9-11 parts of fingered citron, 7-9 parts of nutgrass galingale rhizome, 5-7 parts of weeping forsythiae capsule, 7-8 parts of ginger, 4-5 parts of liquorice, 8-10 parts of dried rehmannia root and 9-13 parts of Chinese angelica.
3. A solubilising formulation of a traditional Chinese medicine composition according to claim 1 or 2, characterised in that it comprises said dry extract powder of traditional Chinese medicine and pharmaceutical excipients, said pharmaceutical excipients comprising a non-ionic surfactant, a glidant, a lubricant and a binder; the weight ratio of the dry powder of the traditional Chinese medicine extract to the auxiliary materials of the medicine is 78-90:10-22.
4. The solubilizing preparation of a Chinese medicinal composition according to claim 3, wherein said nonionic surfactant is a nonionic surfactant having polyethylene glycol as a hydrophilic group.
5. A solubilising formulation for a chinese medicinal composition according to claim 3, characterized in that the non-ionic surfactant is selected from tween, polyoxyethylated castor oil, polyoxyethylated hydrogenated castor oil or vitamin E polyethylene glycol succinic acid.
6. The solubilizing preparation of a traditional Chinese medicine composition according to claim 4, wherein the weight ratio of the nonionic surfactant, the glidant, the lubricant and the binder is: 10-20:0.4-0.8:0.5-1.2:0.03-0.06.
7. The method for preparing the solubilizing preparation of the traditional Chinese medicine composition according to any one of claims 3 to 6, which is characterized by comprising the following steps:
s1, putting the traditional Chinese medicine raw material sections into liquid nitrogen, and freezing for 15-25 min;
s2, grinding the traditional Chinese medicine raw material segments frozen by liquid nitrogen, adding liquid nitrogen again every 4-7 min, grinding to 80-100 meshes, drying, decocting the traditional Chinese medicine powder, concentrating, and spray drying to obtain extract dry powder;
s3, mixing the extract dry powder with a nonionic surfactant, a glidant and an adhesive to obtain a mixture 1;
s4, mixing the mixture 1 with a lubricant, and tabletting to prepare the traditional Chinese medicine composition solubilization preparation.
8. The preparation method according to claim 7, wherein the length of the Chinese medicinal section is 0.3-0.5 cm.
9. The method according to claim 7, wherein the grinding time in step S2 is 50 to 55 minutes; the temperature of the drying is 40-50 ℃.
10. The method according to claim 7, wherein the volume ratio of the Chinese medicine section to the liquid nitrogen in S1 is: 1-2:10.
CN202311457845.9A 2023-10-31 2023-11-04 Traditional Chinese medicine composition for treating breast nodules and preparation method of solubilizing preparation of traditional Chinese medicine composition Pending CN117257909A (en)

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